Applied Clinical Trials
Tom Rhodes, CEO of Spencer Health Solutions, discusses his experiences on how the biopharmaceutical industry has been impacted by COVID, and what some are doing to succeed.
The COVID pandemic has significantly impacted the clinical trials industry, leaving many biopharmaceutical enterprises scrambling to find ways to adapt to this new environment. Many are moving towards implementing decentralized clinical trial processes to keep their studies active and avoid protocol deviations. In this interview, Tom Rhodes, CEO of Spencer Health Solutions, discusses his experiences on how the biopharmaceutical industry has been impacted by COVID, and what some are doing to succeed.
Moe Alsumidaie: What challenges has COVID caused to the clinical trials industry?
Tom Rhodes: COVID is a once-in-a-lifetime issue. The challenges we're seeing are significant for clinical research. Hans Kaspersetz at Life Science Leader indicated roughly 50% of trials are in rescue mode due to the inability of medication delivery to subjects and continuing study visits. For years we spoke about enabling trials for people at home, and now we're at a crossroad, and we have to deliver on that promise. Telehealth is a means to an end and a way to engage people at home.
COVID is a sea change movement. Trial sites aren't seeing patients, and many don't have a telehealth system in place to virtually speak with patients. The lack of study drugs and access to participants makes it difficult for trial progression. Therefore, we've seen roughly 50% of trials go into rescue mode in a matter of weeks. COVID has taken a difficult situation and turned it into an almost impossible one where trials may have to cease altogether until tools are in place.
MA: Where can telemedicine be used to address those challenges caused by COVID? How can telemedicine be used to enhance remote monitoring, safety monitoring, patient retention, or virtual visits?
TR: The beauty of a monitoring system with telehealth, biometric monitoring, and IP compliance is that these programs enable site staff to maintain contact and engagement through an in-home study. Patients have become tech-savvy over the last decade, leading them to be more involved in the conversation so they can use programs in their home that actively communicate with them while ensuring data security, privacy, and protection.
One challenge is navigating a large number of telemedicine platforms available. Many clinical operations personnel struggle with the influx of technology platforms they're asked to use, but proper education and training can help showcase the freedom they provide. Until now, many may have been unaccustomed to video conferencing, but there's an opportunity to help patients engage in new treatment routines to build trust. As technology providers, we are responsible for making these systems simple to use and deploy and ensure they are compliant to be used in clinical trials, and meet healthcare laws, such as HIPAA compliance. Seema Verma, Administrator for the Centers for Medicare and Medicaid Services (CMS), said almost 62 million people need telehealth or remote monitoring to keep them out of the hospital during this pandemic.
MA: Overwhelmed by COVID-related issues, sponsors are bombarded with technology companies offering virtual visits and remote operations. What advice would you give sponsors when evaluating these vendors? What should they look or ask for when interacting with them?
TR: If your evaluation process is robust, it should allow you to scale for speed. Use your method but compress it to reach the timelines that align with your goals. Pharma doesn't need to abandon the process in which technology is evaluated, but the industry needs to make decisions. Before COVID, Pharma companies were willing to pilot decentralized trials, but pilots are not taken far because platform integration isn't widely adopted. However, given the pandemic, some major Pharma players are beginning to think differently and are increasing the number of telehealth providers to conduct study visits remotely. Replacing on-site visits with a video encounter for patients will be the new normal. If the clinical trial industry doesn't adapt, sponsors might not be able to take drugs through the discovery process and receive approvals or stay on track with drugs currently in trials due to challenges with fears associated with patients likening doctors’ offices with COVID transmission.
As the industry evaluates doctor-to-patient-enabling technology, it's critical to consider the impact of everything that could be achieved with a patient. Often an approach is built on antiquated processes that aren't applicable on the home level. Looking for those single platforms that support drug compliance, biometric and data surveys, telehealth access, and aggregating that information is critical in technology evaluations.
MA: What do you think a clinical trial now, in the era of COVID, is going to look like?
TR: Telehealth or home-based hybrid, decentralized trials seem to be areas sponsors are interested in. As we've moved from curiosity to crisis, top winners need to be chosen, and things need to move forward quickly. The med-tech community has been preparing for significant opportunities to better serve and provide services into the home, and I believe telehealth and compliance platforms can fill the gap. As we look beyond COVID, a sea change will be created that highlights hybrid and decentralized trials and potentially full virtual trials. Even areas like Pouch packaging have been affected by COVID. Although Pouch packaging hasn't made a jump on the retail side of the business, we saw a big change when Amazon bought PillPack. Now, Pouch can be found across all major and regional chains and is being rolled out at a breakneck pace. Regarding COVID, we'll see a dramatic and remarkable fast shift to hybrid and home monitoring trials, but a balanced approach will be needed. The med-tech community will need to step up to support Pharma and patients and deliver on its promises.
MA: What will the future of clinical research look like after COVID?
TR: Pharma will evolve its patient engagement toward a longitudinal, home-based strategy. They will use technology to drive patient insights, drug efficacy and tolerance, and support for value-based contracts. You can't commit to outcomes if you don't have oversight on compliance and direct patient feedback. This will lead to better results, advancing drug development, and expanding patient access (by reaching patients in areas that are far from sites). It's a fascinating time right now, and technology has an important role here-to keep Pharma connected with its patients.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.